ALERT project looks to ICT for drug safety

A new EU-funded information and communication technology (ICT) project is tackling issues of safety in newly developed drugs. Over the next three and a half years, the ALERT ('Early detection of adverse drug events by integrative mining of clinical records and biomedical knowledge') project partners will work on an innovative computer system for a better and faster detection of adverse drug reactions (ADRs).

Currently, so-called spontaneous reporting systems are used when side effects are discovered in a drug that is already on the market. Clinicians are responsible for recognising and reporting those side effects. "A number of recent, highly publicised drug safety issues showed that adverse effects of drugs may be detected too late, when millions of patients have already been exposed," the research consortium comments.

With the aim of improving this system, ALERT will analyse data from electronic healthcare records (EHRs) of over 30 million patients from the Netherlands, Denmark, UK, Spain and Italy, using a variety of computational techniques. Those techniques, including text mining and epidemiological computing, will help to retrieve information from the data and detect 'signals', such as combinations of drugs and suspected ADRs that require further investigation.

The focus of the ALERT project will be on side effects in children, as relatively little is known about them and children are particularly vulnerable. Moreover, the interdisciplinary research team will attempt to find a way to discriminate between signals that do indeed indicate an ADR and spurious signals, which might even result in withdrawal of a useful drug from the market. In order to make this distinction, the ALERT researchers will look for a biological explanation for each signal by comparing the side effect with up-to-date knowledge about biological mechanisms. The findings will then be further corroborated in computer simulations and models.

The project partners emphasise that this kind of analysis is a continuous process: "As more patient data become available and medical, biological and molecular knowledge expands, previous conclusions will need to be revisited. In order to deal with this constant process of revision, ALERT will focus on automated procedures as much as possible."

A total of 18 project partners from eight countries are involved in the ALERT project, which is coordinated by the Erasmus University Medical Centre Rotterdam, Netherlands. The project cost amounts to nearly €5.9 million, €4.5 million of which are covered by the EU's Seventh Framework Programme (FP7)

For further information, please visit:
Erasmus University Medical Centre Rotterdam
http://www.erasmusmc.nl/
IMIM Foundation (Fundació Institut Municipal d'Investigació Mèdica), Barcelona
http://www.imim.es/

Copyright ©European Communities, 2008
Neither the Office for Official Publications of the European Communities, nor any person acting on its behalf, is responsible for the use, which might be made of the attached information. The attached information is drawn from the Community R&D Information Service (CORDIS). The CORDIS services are carried on the CORDIS Host in Luxembourg - http://cordis.europa.eu. Access to CORDIS is currently available free-of-charge.

Most Popular Now

Salvat Laboratories announces submission of New Dr…

Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsi...

Pfizer's elranatamab granted FDA Breakthrough Ther…

Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administrati...

New insights on antibody responses to Omicron vari…

Knowing how well vaccination against one SARS-CoV-2 strain (with or without previous infection) counteracts infection with a different strain is a critical research quest...

Ancient viral DNA in human genome guards against i…

Viral DNA in human genomes, embedded there from ancient infections, serve as antivirals that protect human cells against certain present-day viruses, according to new res...

The origin-of-life molecule, a key to cancer resea…

RNA, the molecule that gave rise to life, has been shown to be essential for repairing human genetic material and preventing mutations that might lead to developing cance...

Bayer with continued strong performance

The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we...

Sugar molecules as a target in cancer therapy

Cancer cells use sugar molecules on their surface to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism ...

Vividion Therapeutics names Jenna Goldberg as Chie…

Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision the...

COVID vaccination improves effectiveness of cancer…

Patients with nasopharyngeal cancer are often treated with drugs that activate their immune system against the tumor. Until now, it was feared that vaccination against Co...

Making melanoma immortal: Pitt scientists discover…

Scientists at the University of Pittsburgh School of Medicine have discovered the missing puzzle piece in the mystery of how melanoma tumors control their mortality. I...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron ...

Study reveals vaccine confidence declined consider…

A new study suggests that, despite the success of the COVID-19 vaccination campaigns, vaccine confidence has declined significantly since the start of the pandemic. Re...